section#: 1 title: data oversight office of research and ... · 1 1 c8 data oversight committee ......

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1 C8 Data Oversight Committee

1.1 Purpose

On September 4, 2013, an amended order was entered in Leach v. E.I. du Pont de

Nemours & Co., Civil Action No. 01-C-608 (Circuit Court of Wood County, West

Virginia) designating the West Virginia University (WVU) Robert C. Byrd Health

Sciences Center as the “third party mechanism” for overseeing, implementing,

managing, and administering all data generated as part of the Brookmar Health

Project and/or Science Panel studies. The Office of the Senior Associate Vice

President for WVU Health Sciences Research and Graduate Education was

authorized to designate “Receiving Individuals” within West Virginia University to

assist in meeting the obligations of the “third party mechanism”.

1.2 Policy

A C8 Data Oversight Committee shall be created to implement all aspects of the

amended court order.

1.3 Procedure

The Senior Associate Vice President for WVU Health Science Research and

Graduate Education will periodically appoint individuals affiliated with West

Virginia University to serve on the C8 Data Oversight Committee. This Committee

will assist the Senior Associate Vice President in the implementation of the “third

party mechanism” for data sharing. Members will be selected based on

competence, scientific reliability, and trustworthiness. Members will serve at the

sole discretion of the Senior Associate Vice President, and the court will

periodically be informed of the current membership. This committee shall also

contain one non-voting representative from the WVU Office of the Vice President

for Legal Affairs and General Counsel.

Robert C. Byrd Health Sciences Center

Office of Research and Graduate Education

Section#: 1 Title: Data Oversight Committee 1st Effective 12/08/2015 Reviewed 12/08/2015 C8 Health Project Standard Operating Procedures

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2 Release of C8 Health Project and/or Science Panel Individual Data

2.1 Purpose



Virginia) designating the West Virginia University Robert C. Byrd Health Sciences

Center as the “third party mechanism” for overseeing, implementing, managing,

and administering all data generated as part of the Brookmar Health Project

and/or Science Panel studies.

The relevant portion of the amended order directs the “Receiving Individuals” to

create a process wherein individual members of the Class can receive a copy of

their own, individual information generated from their participation in any of the

studies related to the original lawsuit settlement. The amended order permits

the “Receiving Individuals” to create a mechanism to recover reasonable and

legitimate costs associated with this process.1

1 Given the nature of “All Filed Data”, the “Receiving Individuals” will rely on W.

Va. Code R. §16-29-2 {June 8th, 2014}, as a guide to the identification of costs that

will comprise the user fee. The user fee shall be reviewed annually to ensure the

validity of the associated costs that comprise the user fee, and to index these

costs to account for inflation.



Section#: 2 Title: Individual Class Member Reports 1st Effective 10/16/2014 Reviewed 09/06/2016 C8 Health Project Standard Operating Procedures

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2.2 Definitions

All Filed Data: All data generated pursuant to the Brookmar Health Project

and/or Science Panel Studies

Class Member: An individual who qualifies as a member of the “Class” as defined

by the court in the settlement of Leach v. E.I. du Pont de Nemours & Co., Civil

Action No. 01-C-608 (Circuit Court of Wood County, West Virginia, entered Feb.

24, 2005).

Brookmar Health Project: The purpose of the C8 Health Project was to collect

health data from Class Members of the lawsuit through written questionnaires

and a battery of blood tests, including a test to ascertain the amount of C8 in the

blood. Brookmar, Inc. was appointed by the Circuit Court of Wood County to

conduct the C8 Health Project. Accordingly, the C8 Health Project began testing

on July 27, 2005.

Science Panel Studies: The Science Panel was also appointed by the Circuit Court

of Wood County as a part of the aforementioned Settlement Agreement. The

Science Panel, as part of the Community Study, received the anonymized and

non-identifiable health data collected by Brookmar, Inc. to examine and analyze

as part of its work. In addition, identifiable health data was released to the

Science Panel for those Participants who gave additional specific consents.

Members of the C8 Science Panel were:

Dr. Tony Fletcher, London School of Hygiene and Tropical Medicine

Dr. David Savitz, Brown University

Dr. Kyle Steenland, Emory University

Receiving Individuals: Individuals within West Virginia University and the Office of

the Senior Associate Vice President for WVU Health Sciences Research and

Graduate Education who have access to “All Filed Data” for the purposes of

fulfilling the court’s order.

Requestor: An individual requesting individual level data from the Receiving

Individuals, whether on his/her own behalf or on behalf of a Class Member for

whom they are legally authorized to request and receive data.

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2.3 Policy

The identity of Requestors shall be meticulously verified to ensure that each

Requestor only receive his/her own data or data for Class Members for whom

they are legally authorized to request and receive data.

2.4 Procedure for Release of Data

1) A Requestor will download, print, and complete the C8 Health Project

Individual Data Request Form located at the Robert C. Byrd Health Sciences

Center Office of Research and Graduate Education website

(http://www.hsc.wvu.edu/ResOff/C8/Science-Panel).

2) The Requestor (or his/her legal representative) will sign the completed C8

Health Project Individual Data Request Form and have said form witnessed

and notarized; provided, that notarization is not required for individual

data requests that are part of the Fall 2016 Medical Monitoring Manager

bulk request and are accompanied by other sufficient identity verification.

If the Request Form is signed by someone other than the Class Member,

documentation must be provided to sufficiently document that the Class

Member has provided authority for the representative to request/receive

the Class Member’s data.

3) Individual adult requestors will present two of the following forms of

identification, at least one of which must have a photo, to the Notary

Public for identity verification (this requirement must be fulfilled regardless

of whether the data is requested by the Class Member or his/her legal

representative):

a. Current driver’s License;

b. Current passport or passport card;

c. Certificate of Citizenship;

d. Certificate of Naturalization;

e. Social Security Card or Birth Certificate (original or certified copy);

f. State Issued Photo ID Card;

g. Government Employment ID card;

h. Student Photo ID Card issued by a US school, college, or university;

i. Military Photo ID Card;

j. Major Credit Card or Bank Card with Photo;

k. Resident of U.S. Alien Card;

http://www.hsc.wvu.edu/ResOff/C8/Science-Panel

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l. Official Divorce Decree or Marriage Certificate;

m. Certificate of name change; or

n. Official baptismal record.

4) Requestors seeking the individual data of a child must provide: a. The completed, witnessed, and notarized C8 Health Project

Individual Data Request Form and

b. An original or certified copy of the birth certificate or court-issued

custody papers to prove legal guardianship. 5) Requestors seeking the individual data of a deceased person must

provide: a. The completed, witnessed, and notarized C8 Health Project


b. Sufficient documentation to prove that the individual is either the

administrator or executor of the estate. If there is no estate, then a

certified copy of the death certificate with the Requestor named as

the informant must be provided.

6) Requestors seeking the individual data of any person determined to be

"mentally incompetent," "intellectually disabled," or "mentally

handicapped” must provide:

a. The completed, witnessed, and notarized C8 Health Project


b. Sufficient documentation demonstrating power of attorney or

medical power of attorney/Healthcare Surrogate or other legal

documentation.

7) The Requestor will send the following to the Receiving Individuals via

certified mail with a signature upon delivery required:

a. The completed, witnessed, and notarized C8 Health Project Individual

Data Request Form;

b. The required verification documents (for third party requests); and,

c. A personal check or money order for the amount of the user fee.

8) Upon receipt of the request, the Receiving Individuals shall verify that the

C8 Health Project Individual Data Request Form is complete and accurate.

9) A letter will be sent to the Requestor, asking for a properly executed

authorization or other information if a discrepancy is discovered.

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10) The Receiving Individuals shall deposit the personal check or money order

into an established account..

11) Once the C8 Health Project Individual Data Request Form has been

determined to be complete and accurate and the user fee deposited in an

established account, the Receiving Individuals will generate a database

report containing “all filed data” associated with the individual Class

member.

12) The Receiving Individuals shall assign a password required to open the

document using Adobe Acrobat X™ or later. Importantly, the level of

encryption shall not be less than 256 bit AES.

13) For those Requestors providing an e-mail address, the Receiving

Individuals shall use an established Health Sciences Center (HSC) email

account to e-mail the encrypted report using the HSC’s Secure Web

Delivery (SWD) server. To use the SWD server, the Receiving Individuals

shall insert “[Secure]” in the subject line of every message to ensure that

the report is securely transmitted over the internet to external parties by

encrypting the transmission. Requestors will be required to register with

the SWD system to retrieve the report.

14) The Receiving Individuals will then mail the password necessary to access

the Adobe Acrobat report via certified mail with a signature required upon

delivery.

15) For those Requestors requesting a paper copy of the report, the Receiving

Individuals shall mail the paper copy of the report to the Requestor via

certified mail with a signature required upon delivery. The envelope will be

officially sealed prior to mailing.

16) The Receiving Individuals shall maintain a database detailing the following

information:

a. Date and time that the request for individual information was

received;

b. Date and time that the accuracy of the C8 Health Project Individual

Data Request Form was verified and the name of the receiving

individual conducting the verification;

c. Date and time that the request was fulfilled (i.e. secure e-mail sent or

paper copy mailed);

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d. Date and time mail was received and signed for by the Requestor;

and,

e. Notes detailing issues related to C8 Health Project Individual Data

Request Form verification.

2.5 Cost of Releasing Data to Requestor

1) The user fee for providing Class member reports will be $25 per request

and is based on the following factors:

a. Effort and associated labor costs related to placing the records in

electronic media. These costs include:

i. Development of the Microsoft Access™ database and

reports.

ii. Generation of the individual Microsoft Access™ report.

b. Effort and labor costs related to transmission of the individual

report to the requestor (either electronic or paper).

c. Mailing and supply costs related to transmission of the individual

report to the requestor (either electronic or paper).

2) This fee will be reviewed annually for legitimacy and accuracy, and the

associated costs that comprise the fee will be indexed to account for

inflation.

References

Leach v. E.I. du Pont de Nemours & Co., No. 01-C-608 (Circuit Court of Wood

County, West Virginia, entered Feb. 24, 2005);

Leach v. E.I. du Pont de Nemours & Co., No. 01-C-608 (Circuit Court of Wood

County, West Virginia, entered Sept. 4th, 2013); and,

W. Va. Code §16-29-2 {June 8th, 2014}.

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Section#: 3 Title: Release of Data for Research 1st Effective 12/08/2015 Reviewed 03/21/2016

C8 Health Project Standard Operating Procedures

3 Release of Data for Research Purposes

3.1 Purpose








create “a process wherein members of the scientific or academic communities

may utilize the data in “All Filed Data” and/or related serum stored in the WVU

Tissue Bank for reasons that will benefit science, medicine, human health, the

Class, or society in general.” The amended order permits the “Receiving

Individuals” to create a mechanism to recover reasonable and legitimate costs

associated with this process.

3.2 Definitions

WVU C8 Data Oversight Committee: A group of individuals appointed by the

Senior Associate Vice President for WVU Health Sciences Research and Graduate

Education for the purposes of fulfilling the court’s order.

WVU Affiliated Investigator: Any individual that is formally affiliated with West

Virginia University either by employment or academic appointment and is eligible

to serve as a principal investigator on an application submitted to the West

Virginia University Institutional Review Board.

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Non-affiliated Investigator: Any individual that is not formally affiliated with West

Virginia University either by employee status or academic appointment.

Receiving Individuals: Individuals within West Virginia University and the Office of

the Senior Associate Vice President for WVU Health Sciences Research and

Graduate Education that have been given access to “All Filed Data” for the

purposes of fulfilling the court’s order.

All Filed Data: All data generated pursuant to the Brookmar Health Project

and/or Science Panel Studies

Class Member: An individual who qualifies as a member of the “Class” as defined

by the court in the settlement of Leach v. E.I. du Pont de Nemours & Co., Civil

Action No. 01-C-608 (Circuit Court of Wood County, West Virginia, entered Feb.

24, 2005).

Brookmar Health Project: The purpose of the C8 Health Project was to collect

health data from Class Members of the lawsuit through written questionnaires

and a battery of blood tests, including a test to ascertain the amount of C8 in the

blood. Brookmar, Inc. was appointed by the Circuit Court of Wood County to

conduct the C8 Health Project. Accordingly, the C8 Health Project began testing

on July 27, 2005.

Science Panel Studies: The Science Panel was also appointed by the Circuit Court

of Wood County as a part of the aforementioned Settlement Agreement. The

Science Panel, as part of the Community Study, received the anonymized and

non-identifiable health data collected by Brookmar, Inc. to examine and analyze

as part of its work. In addition, identifiable health data was released to the

Science Panel for those Participants who gave additional specific consents.

Members of the C8 Science Panel were:

Dr. Tony Fletcher, London School of Hygiene and Tropical Medicine

Dr. David Savitz, Brown University

Dr. Kyle Steenland, Emory University

Serums: C8 serum samples obtained as part of the Brookmar Health Project that

are currently stored in the WVU Tissue Bank.

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3.3 Policy

The Receiving Individuals shall create procedures related to releasing C8 data for

research purposes that honor the primacy of protecting the identity and

anonymity of individuals. Therefore, studies that do not require direct access to

data are preferred followed by studies that require access to de-identified data.

All researchers requiring direct access to data will be required to have both a

valid, Institutional Review Board (IRB) approved protocol and project approval

from the WVU C8 Data Oversight Committee prior to accessing any existing C8

Health Project data and/or Science Panel Studies (electronic and serum). The C8

Data Oversight Committee will ensure that proposed studies are both consistent

with the Court’s order dated January 25th, 2013 and will benefit science,

medicine, human health, the Class, or society in general.

3.4 Procedures

3.4.1 West Virginia University Affiliated Investigator

1) The principal investigator shall obtain IRB approval for the research project

from the West Virginia University Institutional Review Board

2) For each proposed research project, a copy of the following should be e-

mailed to [email protected] preparation for review by the West

Virginia University C8 Data Oversight Committee (as applicable):

a. The West Virginia University IRB approval letter

b. The West Virginia University IRB approved variable list

c. The approved Health Insurance Portability and Accountability Act

(HIPAA) waiver of authorization

d. Approved and watermarked informed consent documents

e. Approved advertisements and/or recruitment letters

f. A completed C8 Health Project Data Request form

g. The C8 Health Project Data Use Agreement

3) Upon receipt of the required documents, the C8 project coordinator will

electronically send the documents by e-mail to one C8 Data Oversight

Committee member for scientific review.

4) The C8 Data Oversight Committee scientific reviewer will send the protocol

along with a recommendation to the C8 Project Coordinator.

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5) The C8 project coordinator will e-mail the protocol along with the

recommendation of the C8 Data Oversight Committee scientific reviewer to

all current members of the WVU C8 Data Oversight Committee for review,

and solicit a vote of approve, disapprove, or defer pending more

information. A simple majority of the current WVU C8 Data Oversight

Committee shall be required to ratify any action. In cases where a simple

majority cannot be obtained via electronic means, the research protocol

will be placed on the agenda of the next scheduled meeting for further

discussion.

6) The C8 project coordinator will formally notify the principal investigator

once a committee decision has been reached.

3.4.2 Non-affiliated Investigator

1) The principal investigator shall obtain IRB approval for the research project

from an IRB registered with the United States Office of Human Research

Protections with a federalwide assurance number (FWA).

2) For each proposed research project, a copy of the following should be

emailed to [email protected], in preparation for review by the West

Virginia University C8 Data Oversight Committee:

a. The IRB approval letter

b. A copy of the approved IRB protocol with all associated attachments

including an approved Health Insurance Portability and

Accountability Act (HIPAA) waiver of authorization (if applicable)

c. A completed C8 Health Project Data Request form

d. The C8 Health Project Data Use Agreement form

e. Detailed code or other analysis details to be conducted by personnel

at West Virginia University

3) Upon receipt of the required documents, the C8 project coordinator will

electronically send the documents by e-mail to one C8 Data Oversight

Committee member for scientific review.

4) The C8 Data Oversight Committee scientific reviewer will send the protocol

along with a recommendation to the C8 Project Coordinator.

5) The C8 project coordinator will e-mail the protocol along with the

recommendation of the C8 Data Oversight Committee scientific reviewer to

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all current members of the West Virginia University C8 Data Oversight

Committee for review, and solicit a vote of approve, disapprove, or defer

pending more information. A simple majority of the current West Virginia

University C8 Data Oversight Committee shall be required to ratify any

action. In cases where a simple majority cannot be obtained via electronic

means, the research protocol will be placed on the agenda of the next

scheduled meeting for further discussion.

3.5 Release of Electronic Data for Research

For approved research requests for electronic data, a limited electronic datafile

will be placed on a secure, internal WVU Health Sciences Center server. The

datafiles themselves will be encrypted and password protected with a randomly

generated password for each file.

Access to each file will be granted based on username and restricted to only the

individual(s) listed in the IRB approved protocol. The file will only contain data

elements listed in the approved IRB protocol, and the server/data will only be

accessible from the WVU HSC internal network by WVU affiliated investigators.

Pursuant to the amended court order, investigators external to WVU are not

permitted to receive individual level data (de-identified or identified), unless

partnering with a WVU affiliated principal investigator (see standard operating

procedure 3.7). Whenever possible, a copy of this file should not be downloaded

from the server to an individual computer. If a copy is downloaded from the

server for analysis, the copy shall be destroyed according to the guidelines set

forth in the executed C8 Data Use Agreement. It is the responsibility of the WVU

affiliated investigator to notify the C8 project coordinator at

[email protected] the data analysis is complete so that the

electronically created file can be deleted from the C8 server.

3.6 Release of Serum Samples for Research

The C8 serum samples were not originally collected for research purposes, and

thus not subjected to rigorous scientific controls. More specifically, these

samples were a) not flash frozen; b) have had an unknown amount of time at

room (or not -80C) temperature; and, c) have undergone multiple freeze-thaw

cycles. Therefore, the samples are of unclear quality and may not be valid for

certain types of assays /detection of some molecules, in particular proteins and

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miRNA. Given this situation, all investigators, whether WVU affiliated or non-

affiliated, requesting serums for use in research will be required to address this

issue in their application. At a minimum, investigators must supply valid,

supporting documentation that the proposed analyses will be scientifically valid in

the face of the caveats of these samples.

To prevent freeze-thaw damage and thus preserve the integrity of the serums,

approved research requests for serums shall be fulfilled no greater than four

times in a calendar year. Researchers with approved serum requests will be

informed of the approximate date when the next requests will be fulfilled.

Pursuant to the amended court order, investigators external to WVU are not

permitted to receive individual level data (de-identified or identified), unless

partnering with a WVU affiliated principal investigator (see standard operating

procedure 3.7).

3.6.1 Disclaimer Statement

Notice on the Methods for the Collection, Processing, Handling, and Storage of

the Stored Serum Samples: Samples available for research are the residual serum

samples remaining after PFC analysis for the C8 Health Project was completed. All

samples were collected in 2005-2006, and there is variation in the amount of

sample remaining for each participant which may limit capacity to repeat

experiments and therefore, reproducibility. It should be noted that, when

collected, the samples were not specifically intended for inclusion in additional

research projects. As such, for each sample the time from collection to initial

freeze, and number of freeze-thaw cycles cannot be determined. The general

collection and processing procedures, therefore, may not meet the most rigorous

laboratory standards for specific types of analyses and individual researchers

must consider how sample age, processing, and freeze-thaw cycles affect the

biological targets being measured in these samples. [Prospective researchers will

be required to acknowledge in writing this sample disclaimer and include the

statement below in any forum (e.g., manuscript, grant, proposal, or presentation,

etc.) that proposes the use of or reports the results from analysis of these

samples.]

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3.6.2 Disclaimer Statement: For inclusion in manuscripts, grants, proposals, presentations, etc.:

“It is acknowledged and disclosed here that the residual samples from the

C8 Health Project, collected during 2005-2006, have heterogeneity with

regard to processing, including the number of freeze-thaw cycles

subsequent to original analysis. All results reported here/analyses

proposed here must be interpreted within the context of these limitations,

which are more fully described elsewhere

[http://www.hsc.wvu.edu/resoff/research/c8/]”.

3.7 Access to Individual Level Data for Non-affiliated Investigators

Non-affiliated investigators seeking access to individual level data must partner

with a WVU affiliated principal investigator, and be listed on an approved

protocol by the WVU IRB. After fulfilling the requirements listed in sections 3.4.1

and 3.4.2, a non-affiliated investigator may be granted access to a limited

electronic datafile as described in section 3.5. Access to this file is only possible

from the campus of West Virginia University. Non-affiliated investigators who

have been granted access shall make arrangements with the C8 project

coordinator ([email protected]) for travel to the Health Sciences

Center campus to analyze the datafile.

Non-affiliated investigators seeking to analyze serum samples should contact the

C8 project coordinator as soon as possible to query the possibility of analyzing

such samples on the campus of West Virginia University. Such analyses may incur

additional costs specific to the project and the nature the request.

3.8 Future Research using the Existing De-Identified C8 Dataset

Prior to the amended court order dated September 4, 2013 that released

identifiers to the West Virginia University (WVU) Robert C. Byrd Health Sciences

Center, investigators at the Robert C Byrd Health Sciences Center partnered

directly with Brookmar, Inc. to clean and provide summary analyses of de-

identified C8 data. Some additional research activities using this original de-

http://www.hsc.wvu.edu/resoff/research/c8/

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identified dataset under WVU IRB #17015-E (approved August 21, 2006) were

conducted.

Any additional research activities using this de-identified C8 dataset will require

submission, review, and approval of a WVU IRB expedited category 5 protocol.

Upon approval of the protocol, the investigator shall be required to notify the C8

project coordinator and provide a copy of the approved protocol. Prior to

commencement of the research, investigators will also be required to sign the C8

Data Use Agreement.

3.9 Cost of Releasing Data to Investigators

1) The user fee for providing investigators with data will vary depending on

the following factors:

a. Effort and associated labor costs related to retrieving requested

data (electronic and serum).

b. Effort and associated labor costs related to data analysis and report

preparation.

c. Mailing and supply costs related to transmission of research data

(including serums) and/or reports to investigators.

2) The factors comprising each fee will be itemized and made available to

the requesting investigator and to the Court upon request.

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Section#: 4 Title: Policy on Publications 1st Effective 12/08/2015 Reviewed 12/08/2015

C8 Health Project Standard Operating Procedures

4 Publications

4.1 Purpose








“create a mechanism for monitoring how results from conducted studies are used

and disseminated in a manner consistent with the intent to benefit science,

medicine, human health, the Class, or society in general”.

4.2 Policy

All peer-reviewed publications, including published abstracts presented at

national and international meeting as well as full manuscripts, shall be reported

to the C8 Data Oversight Committee.

4.3 Procedure

Investigators shall send the following items in a timely manner to the C8 project

coordinator at [email protected]:

1) Final published pdf copies of the report, abstract, or peer-reviewed

manuscript.

2) Any other citation or presentation information including the date and

venue of presentation.

section#: 1 title: data oversight office of research and ... · 1 1 c8 data oversight committee ......

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